Gastroesophageal Junction AdenocarcinomaPhase 3NCT04375605

Neoadjuvant RCT Versus CT for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the GEJ

A Phase 3 study testing 5-Fluorouracil, Calcium folinate and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma, run by Universitätsmedizin Mannheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing neoadjuvant radiochemotherapy with FLOT versus FLOT chemotherapy alone für patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastroesophageal Junction Adenocarcinoma
What is being tested?: 5-Fluorouracil, Calcium folinate and Oxaliplatin
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 342 participants
Where: 1 siteGermany
Study dates: 3 Jun 2020to 30 Jun 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically proven, locally advanced and potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert I- III) that is: cT3-4, any N, M0 or cT2 N+, M0 according to AJCC 8th edition
Patients* must be candidates for potential curative resection as determined by the treating surgeon
ECOG performance status 0-1
Age 18 years or above
Adequate hematologic function with absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l, platelets ≥ 100 x 10^9/l and hemoglobin ≥ 9.0 mg/dl
INR <1.5 and aPTT<1.5 x upper limit of normal (ULN) within 7 days prior to randomization

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Adequate liver function as measured by serum transaminases (ASAT, ALAT) ≤ 2.5 x ULN and total bilirubin ≤ 1.5 x ULN
Adequate renal function with serum creatinine ≤ 1.5 x ULN
QTc interval (Bazett*) ≤ 440 ms
Written informed consent obtained before randomization
Negative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice highly effective*** contraceptive measures during the study and for 6 months after the end of study treatment. Male patients must also agree to refrain from father a child during treatment and up to 6 months afterwards and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.
*There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.
** formula for QTc interval calculation (Bazett): QTc= ((QT) ̅" (ms)" )/√(RR (sec))= ((QT) ̅" (ms)" )/√(60/(Frequence (1/min)))
*** highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).

Who cannot join

Evidence of metastatic disease (exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI [if osseous lesions are suspected due to clinical signs])
Past or current history (within the last 5 years prior to treatment start) of other malignancies. Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible
Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 4.03
Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
Pregnant or lactating females
Patients medically unfit for chemotherapy and radiotherapy

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Patients receiving any immunotherapy, cytotoxic chemotherapy or radiotherapy other than defined by the protocol. The participation in another clinical trial with the use of investigational agents, chemotherapy or radiotherapy during the trial is not permitted
Known hypersensitivity against 5-FU, folinc acid, oxaliplatin or docetaxel
Other known contraindications against 5-FU, folinic acid, oxaliplatin, or docetaxel
Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
Clinically significant valvular defect
Other severe internal disease or acute infection
Peripheral polyneuropathy > NCI Grade II according to CTCAE version 4.03
Chronic inflammatory bowel disease

Trial locations and contacts

1 site in 1 country.

Germany1 site

Unversity Hospital Mannheim
Mannheim, 68167

Other trials in Germany

About this study

Official title: RACE-trial: Neoadjuvant Radiochemotherapy Versus Chemotherapy for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) A Randomized Phase III Joint Study of the AIO, ARO and DGAV

Read the detailed description

The RACE trial seeks to demonstrate superiority of preoperative FLOT induction chemotherapy followed by preoperative radiochemotherapy and postoperative FLOT chemotherapy over perioperative FLOT chemotherapy without radiotherapy in patients with adenocarcinoma of the gastroesophageal junction undergoing adequate oncological surgery.

Eligible patients will be randomly allocated to one of two treatment groups, i.e. preoperative chemotherapy (Arm A) or preoperative chemotherapy with subsequent preoperative radiochemotherapy (arm B), both followed by resection and postoperative completion of chemotherapy. Randomization will occur in a 1:1 ratio with stratification by primary tumor site (Siewert I vs. Siewert II/III).

Arm A:

Patients randomized to Arm A (control arm) will be treated with four preoperative cycles of FLOT. Cycles will be repeated every two weeks. The preoperative chemotherapy duration in Arm A is eight weeks. Surgical resection will follow 4-6 weeks after day 1 of the last cycle of neoadjuvant therapy. Postoperative chemotherapy will start 6-12 weeks after surgery and consists of another four cycles of FLOT every two weeks. The total treatment period is 25-32 weeks.

Arm B:

Patients randomized in Arm B (experimental arm) will be treated with two cycles of FLOT every two weeks. Radiochemotherapy will start three weeks after day 1 of the second cycle and consists of oxaliplatin and infusional 5-fluorouracil plus concurrent radiotherapy given to a dose of 45 Gy (25 daily fractions with 1.8 Gy) over five weeks. The preoperative treatment duration is 10 weeks. Surgical resection will follow 4-6 weeks after last treatment with chemotherapy / radiation. Postoperative chemotherapy will start 6-12 weeks after surgery and consists of four cycles of FLOT every two weeks. The total treatment period is 26-33 weeks.

Conditions: Gastroesophageal Junction Adenocarcinoma
Being tested: 5-Fluorouracil, Calcium folinate, Oxaliplatin, Docetaxel, Radiation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5-FluorouracilDrug
Day 1 q2w: 2600 mg/m² IV over 24 hours
Calcium folinateDrug
Also called Folinic Acid
Day 1 q2w: 200 mg/m² IV over 2 hours
OxaliplatinDrug
Day 1 q2w: 85 mg/m² IV over 2 hours
DocetaxelDrug
Day 1 q2w: 50 mg/m² IV over 2 hours
RadiationRadiation
25 fractions (5 each week over 5 weeks) each 1,8 Gy to a total of 45 Gy
Oxaliplatin during radiotherapyDrug
Day 1, 8, 15, 22, 29: 45 mg/m² IV over 2 hours
5-Fluorouracil during radiotherapyDrug
day 1 - 33: 225 mg/m²/day IV continuously

Study groups in NCT04375605
Study group	Role	What they receive
Arm A (control arm)	Active comparator	Patients randomized in control arm A will receive four cycles of neoadjuvant chemotherapy with FLOT every two weeks (5-FU 2600 mg/m² d1, folinc acid 200 mg/m² d1, oxaliplatin 85 mg/m² d1, docetaxel 50 mg/m² d1) followed by surgical resection 4-6 weeks after day 1 of the last cycle of neoadjuvant therapy. 6-12 weeks after surgery adjuvant chemotherapy starts with 4 cycles of FLOT (total treatment period 25-32 weeks). Receives: Drug: 5-Fluorouracil; Drug: Calcium folinate; Drug: Oxaliplatin; Drug: Docetaxel
Arm B (experimental arm)	Experimental	Patients randomized in experimental arm B will receive two cycles of neoadjuvant induction chemotherapy with FLOT (5-FU 2600 mg/m² d1, folinic acid 200 mg/m² d1, oxaliplatin 85 mg/m² d1, docetaxel 50 mg/m² d1) every two weeks (4 weeks of therapy) followed by radiochemo-therapy beginning at day 21 after day one of the last cycle of chemotherapy. Radiochemotherapy consists of oxaliplatin 45 mg/m² weekly (d1, 8, 15, 22, 29) and continuous infusional 5-FU 225 mg/m² plus concurrent radiotherapy given in 5/week fractions with 1.8 Gy to a dose of 45 Gy over 5 weeks. Resection is performed 4-6 weeks after last treatment with chemotherapy / radiation. Adjuvant treatment starts 6-12 weeks after surgery and consists of 4 cycles of FLOT (total treatment period of 26 - 33 weeks). Receives: Drug: 5-Fluorouracil; Drug: Calcium folinate; Drug: Oxaliplatin; Drug: Docetaxel; Radiation: Radiation; Drug: Oxaliplatin during radiotherapy; Drug: 5-Fluorouracil during radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of PFS between arms
to compare PFS in patients with resectable GEJ adenocarcinoma receiving perioperative FLOT alone versus perioperative FLOT combined with neoadjuvant radiochemotherapy where PFS ist defined as the time from randomization to disease progression or disease recurrence after surgery or death from any cause
Measured: up to 5 years

Secondary outcomes (7)

Overall survival (OS)
Overall survival (OS) where OS is defined as the time from randomization to death from any cause
Measured: up to 5 years
R0 resection rate
R0 resection rate where R0 resection is defined as microscopically margin negative resection with no gross or microscopic tumor remains in the areas of the primary tumor and/or samples regianal lymph nodes based on evaluation by the local pathologist.
Measured: after surgery, approx. 12 weeks after randomization
Number of harvested lymph nodes
Number of harvested lymph nodes during surgery
Measured: after surgery, approx. 12 weeks after randomization
Site of tumor relapse
Site of tumor relapse if tumor recurrence/relapse occurs
Measured: 5 years
Overall survival rate at 1, 3 and 5 years
Overall survival rate is defined as the proportion of patients known to be alive at 1, 3 or 5 years after randomization
Measured: 1 year, 3 years, 5 years
Patient reported outcomes: quality of life according to questionnaire EORTC-QLQ-C30
quality of life scores according to validated questionnaires EORTC-QLQ-C30
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 68 months
Patient reported outcomes: quality of life according to questionnaire EORTC module OG25
quality of life scores according to validated questionnaire EORTC module OG25
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 68 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202030 Jun 2026

First posted5 May 2020
Study start3 Jun 2020
Primary completion30 Jun 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04375605
Sponsor's protocol ID: RACE
Other IDs: 2018-001728-20, AIO-STO-0118, 2024-516271-32-00, 2018
Status last verified: Jul 2026
First submitted: 21 Apr 2020
Last updated: 7 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.
PubMed 40340830
Lorenzen S, Biederstadt A, Ronellenfitsch U, Reissfelder C, Monig S, Wenz F, Pauligk C, Walker M, Al-Batran SE, Haller B, Hofheinz RD. RACE-trial: neoadjuvant radiochemotherapy versus chemotherapy for patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction - a randomized phase III joint study of the AIO, ARO and DGAV. BMC Cancer. 2020 Sep 15;20(1):886. doi: 10.1186/s12885-020-07388-x.
PubMed 32933498

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroesophageal Junction Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RACE-trial: Neoadjuvant Radiochemotherapy Versus Chemotherapy for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) A Randomized Phase III Joint Study of the AIO, ARO and DGAV
ClinicalTrials.gov ID: NCT04375605
Acronym / sponsor ID: RACE
Conditions: Gastroesophageal Junction Adenocarcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 342 participants (actual)
Lead sponsor: Universitätsmedizin MannheimUniversity, hospital or other
Collaborators: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, Deutsche Krebshilfe e.V., Bonn (Germany)
Study start: 3 Jun 2020 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 5 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Arm A:

Arm B:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A (control arm)	Active comparator	Drug: 5-Fluorouracil, Drug: Calcium folinate, Drug: Oxaliplatin, Drug: DocetaxelPatients randomized in control arm A will receive four cycles of neoadjuvant chemotherapy with FLOT every two weeks (5-FU 2600 mg/m² d1, folinc acid 200 mg/m² d1, oxaliplatin 85 mg/m² d1, docetaxel 50 mg/m² d1) followed by surgical resection 4-6 weeks after day 1 of the last cycle of neoadjuvant therapy. 6-12 weeks after surgery adjuvant chemotherapy starts with 4 cycles of FLOT (total treatment period 25-32 weeks).
Arm B (experimental arm)	Experimental	Drug: 5-Fluorouracil, Drug: Calcium folinate, Drug: Oxaliplatin, Drug: Docetaxel, Radiation: Radiation, Drug: Oxaliplatin during radiotherapy, Drug: 5-Fluorouracil during radiotherapyPatients randomized in experimental arm B will receive two cycles of neoadjuvant induction chemotherapy with FLOT (5-FU 2600 mg/m² d1, folinic acid 200 mg/m² d1, oxaliplatin 85 mg/m² d1, docetaxel 50 mg/m² d1) every two weeks (4 weeks of therapy) followed by radiochemo-therapy beginning at day 21 after day one of the last cycle of chemotherapy. Radiochemotherapy consists of oxaliplatin 45 mg/m² weekly (d1, 8, 15, 22, 29) and continuous infusional 5-FU 225 mg/m² plus concurrent radiotherapy given in 5/week fractions with 1.8 Gy to a dose of 45 Gy over 5 weeks. Resection is performed 4-6 weeks after last treatment with chemotherapy / radiation. Adjuvant treatment starts 6-12 weeks after surgery and consists of 4 cycles of FLOT (total treatment period of 26 - 33 weeks).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Histologically proven, locally advanced and potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert I- III) that is: cT3-4, any N, M0 or cT2 N+, M0 according to AJCC 8th edition
Patients* must be candidates for potential curative resection as determined by the treating surgeon
ECOG performance status 0-1
Age 18 years or above
Adequate hematologic function with absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l, platelets ≥ 100 x 10^9/l and hemoglobin ≥ 9.0 mg/dl

Key exclusion criteria (14 listed)

Evidence of metastatic disease (exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI [if osseous lesions are suspected due to clinical signs])
Past or current history (within the last 5 years prior to treatment start) of other malignancies. Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible
Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 4.03
Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
Pregnant or lactating females

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5-FluorouracilDay 1 q2w: 2600 mg/m² IV over 24 hours	Drug	Arm A (control arm), Arm B (experimental arm)
Calcium folinateAlso: Folinic AcidDay 1 q2w: 200 mg/m² IV over 2 hours	Drug	Arm A (control arm), Arm B (experimental arm)
OxaliplatinDay 1 q2w: 85 mg/m² IV over 2 hours	Drug	Arm A (control arm), Arm B (experimental arm)
DocetaxelDay 1 q2w: 50 mg/m² IV over 2 hours	Drug	Arm A (control arm), Arm B (experimental arm)
Radiation25 fractions (5 each week over 5 weeks) each 1,8 Gy to a total of 45 Gy	Radiation	Arm B (experimental arm)
Oxaliplatin during radiotherapyDay 1, 8, 15, 22, 29: 45 mg/m² IV over 2 hours	Drug	Arm B (experimental arm)
5-Fluorouracil during radiotherapyday 1 - 33: 225 mg/m²/day IV continuously	Drug	Arm B (experimental arm)

Primary outcome

Comparison of PFS between arms
Time frame: up to 5 years
to compare PFS in patients with resectable GEJ adenocarcinoma receiving perioperative FLOT alone versus perioperative FLOT combined with neoadjuvant radiochemotherapy where PFS ist defined as the time from randomization to disease progression or disease recurrence after surgery or death from any cause

7 secondary outcomes

Overall survival (OS)
Time frame: up to 5 years
R0 resection rate
Time frame: after surgery, approx. 12 weeks after randomization
Number of harvested lymph nodes
Time frame: after surgery, approx. 12 weeks after randomization
Site of tumor relapse
Time frame: 5 years
Overall survival rate at 1, 3 and 5 years
Time frame: 1 year, 3 years, 5 years
Patient reported outcomes: quality of life according to questionnaire EORTC-QLQ-C30
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 68 months
Patient reported outcomes: quality of life according to questionnaire EORTC module OG25
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 68 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Derived from this study: PubMed 40340830Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.
Derived from this study: PubMed 32933498Lorenzen S, Biederstadt A, Ronellenfitsch U, Reissfelder C, Monig S, Wenz F, Pauligk C, Walker M, Al-Batran SE, Haller B, Hofheinz RD. RACE-trial: neoadjuvant radiochemotherapy versus chemotherapy for patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction - a randomized phase III joint study of the AIO, ARO and DGAV. BMC Cancer. 2020 Sep 15;20(1):886. doi: 10.1186/s12885-020-07388-x.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ralf-Dieter Hofheinz, Prof. Dr. principal investigator

Universitätsmedizin Mannheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-Fluorouracil, Calcium folinate and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma, run by Universitätsmedizin Mannheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of PFS between arms (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04375605, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.